The view from the Director’s office
AHL is often asked to develop a new test for diseases that may be emerging, rare or challenging to diagnose. In each case, specific criteria must be considered before a new test is offered to clients. These criteria include: resources required to validate the test; availability of positive and negative samples for assay controls and the validation process; significance of the disease to the particular animal sector; and market volume. Since AHL is accredited to the ISO/IEC 17025:2017 standard by Standards Council of Canada, in addition to accreditation by the AAVLD, there are stringent requirements that need to be followed whenever a new test is added in order to ensure compliance with our rigorous quality system program.
Validation of a new test requires completion of an internal or inter-laboratory comparison using known positive and negative samples. Performance characteristics of the test (sensitivity, specificity, accuracy, reproducibility) are determined, and a decision is made regarding whether the test is “fit for use”. Resources required for the validation step include staff time and supply costs, typically $3,000-$5,000 per test. If a test requires full accreditation, additional costs are incurred, including the purchase and performance of annual proficiency tests.
Therefore, the decision to develop and offer a new test depends upon a balance between resource availability, and the industry’s needs and willingness to submit sufficient samples to warrant maintaining the test in AHL’s inventory. For those tests that don’t meet these criteria, there is always the option to refer it to another laboratory that is already performing the test. Please contact AHL Client Services if you are looking for a test that is not listed in AHL’s User’s Guide and Fee Schedule, and we will do our best to find a laboratory that can conduct the test for you.
And on that note, please check out the list of new tests developed in 2022 in this issue!
Maria Spinato, Director
Animal Health Laboratory, University of Guelph, Guelph, ON.